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A Pilot Randomized Controlled Trial to Assess the Impact of Motivational Interviewing on Initiating Behavioral Therapy for Migraine
Minen, Mia T; Sahyoun, Gabriella; Gopal, Ariana; Levitan, Valeriya; Pirraglia, Elizabeth; Simon, Naomi M; Halpern, Audrey
BACKGROUND:Relaxation, biofeedback, and cognitive behavioral therapy are evidence-based behavioral therapies for migraine. Despite such efficacy, research shows that only about half of patients initiate behavioral therapy recommended by their headache specialists. OBJECTIVE:Motivational interviewing (MI) is a widely used method to help patients explore and overcome ambivalence to enact positive life changes. We tested the hypothesis that telephone-based MI would improve initiation, scheduling, and attending behavioral therapy for migraine. METHODS:Single-blind randomized controlled trial comparing telephone-based MI to treatment as usual (TAU). Participants were recruited during their appointments with headache specialists at two sites of a New York City medical center. INCLUSION CRITERIA/METHODS:ages from 16 to 80, migraine diagnosis by United Council of Neurologic Subspecialty fellowship trained and/or certified headache specialist, and referral for behavioral therapy for prevention in the appointment of recruitment. EXCLUSION CRITERIA/METHODS:having done behavioral therapy for migraine in the past year. Participants in the MI group received up to 5 MI calls. TAU participants were called after 3 months for general follow-up data. The prespecified primary outcome was scheduling a behavioral therapy appointment, and secondary outcomes were initiating and attending a behavioral therapy appointment. RESULTS:76 patients were enrolled and randomized (MI = 36, TAU = 40). At baseline, the mean number of headache days was 12.0 ± 9.0. Self-reported anxiety was present for 36/52 (69.2%) and depression for 30/52 (57.7%). Follow-up assessments were completed for 77.6% (59/76, MI = 32, TAU = 27). The mean number of MI calls per participant was 2.69 ± 1.56 [0 to 5]. There was a greater likelihood of those in the MI group to initiating an appointment (22/32, 68.8% vs 11/27, 40.7%, P = .0309). There were no differences in appointment scheduling or attendance. Reasons stated for not initiating behavioral therapy were lack of time, lack of insurance/funding, prioritizing other treatments, and travel plans. CONCLUSIONS:Brief telephone-based MI may improve rates of initiation of behavioral therapy for migraine, but other barriers appear to lessen the impact on scheduling and attending behavioral therapy appointments.
PMID: 31981227
ISSN: 1526-4610
CID: 4274212
Impact of sleep on complicated grief severity and outcomes
Szuhany, Kristin L; Young, Allison; Mauro, Christine; Garcia de la Garza, Angel; Spandorfer, Julia; Lubin, Rebecca; Skritskaya, Natalia A; Hoeppner, Susanne S; Li, Meng; Pace-Schott, Ed; Zisook, Sidney; Reynolds, Charles F; Shear, M Katherine; Simon, Naomi M
BACKGROUND:Complicated grief (CG) is characterized by persistent, impairing grief after losing a loved one. Little is known about sleep disturbance in CG. Baseline prevalence of subjective sleep disturbance, impact of treatment on sleep, and impact of mid-treatment sleep on CG and quality of life outcomes were examined in adults with CG in secondary analyses of a clinical trial. METHODS:Patients with CG (n = 395, mean age =53.0; 78% female) were randomized to CGT+placebo, CGT+citalopram (CIT), CIT, or placebo. Subjective sleep disturbance was assessed by a grief-anchored sleep item (Pittsburgh Sleep Quality Index: PSQI-1) and a four-item sleep subscale of the Quick Inventory of Depressive Symptomatology (QIDS-4). Sleep disturbance was quantified as at least one QIDS-4 item with severity ≥2 or grief-related sleep disturbance ≥3 days a week for PSQI-1. Outcomes included the Inventory of Complicated Grief (ICG), Work and Social Adjustment Scale (WSAS), and Clinical Global Impressions Scale. RESULTS:Baseline sleep disturbance prevalence was 91% on the QIDS-4 and 46% for the grief-anchored PSQI-1. Baseline CG severity was significantly associated with sleep disturbance (QIDS-4: p = .015; PSQI-1: p = .001) after controlling for comorbid depression and PTSD. Sleep improved with treatment; those receiving CGT+CIT versus CIT evidenced better endpoint sleep (p = .027). Mid-treatment QIDS-4 significantly predicted improvement on outcome measures (all p < .01), though only WSAS remained significant after adjustment for mid-treatment ICG (p = .02). CONCLUSIONS:Greater CG severity is associated with poorer sleep beyond PTSD and depression comorbidity. Additional research including objective sleep measurement is needed to optimally elucidate and address sleep impairment associated with CG.
PMID: 31916662
ISSN: 1520-6394
CID: 4257522
Circulating PACAP peptide and PAC1R genotype as possible transdiagnostic biomarkers for anxiety disorders in women: a preliminary study
Ross, Rachel A; Hoeppner, Susanne S; Hellberg, Samantha N; O'Day, Emily B; Rosencrans, Peter L; Ressler, Kerry J; May, VÃctor; Simon, Naomi M
Pituitary adenylate cyclase activating polypeptide (PACAP, gene Adcyap1) is a neuropeptide and hormone thought to play a critical role in stress response (Stroth et al., Ann NY Acad Sci 1220:49-59, 2011; Hashimoto et al., Curr Pharm Des 17:985-989, 2011). Research in humans implicates PACAP as a useful biomarker for the severity of psychiatric symptoms in response to psychological stressors, and work in rodent models suggests that PACAP manipulation exerts downstream effects on peripheral hormones and behaviors linked to the stress response, providing a potential therapeutic target. Prior work has also suggested a potential sex difference in PACAP effects due to differential estrogen regulation of this pathway. Therefore, we examined serum PACAP and associated PAC1R genotype in a cohort of males and females with a primary diagnosis of generalized anxiety disorder (GAD) and nonpsychiatric controls. We found that, while circulating hormone levels were not associated with a GAD diagnosis overall (p = 0.19, g = 0.25), PACAP may be associated with GAD in females (p = 0.04, g = 0.33). Additionally, among patients with GAD, the risk genotype identified in the PTSD literature (rs2267735, CC genotype) was associated with higher somatic anxiety symptom severity in females but lower somatic anxiety symptom severity in males (-3.27, 95%CI [-5.76, -0.77], adjusted p = 0.03). Taken together, the associations between the risk genotype, circulating PACAP, and somatic anxiety severity were stronger among females than males. These results indicate a potential underlying biological etiology for sex differences in stress-related anxiety disorders that warrants further study.
PMID: 31910434
ISSN: 1740-634x
CID: 4257222
Commentary on evidence in support of a grief-related condition as a DSM diagnosis
Simon, Naomi M; Shear, M Katherine; Reynolds, Charles F; Cozza, Stephen J; Mauro, Christine; Zisook, Sidney; Skritskaya, Natalia; Robinaugh, Donald J; Malgaroli, Matteo; Spandorfer, Julia; Lebowitz, Barry
The death of a loved one is one of life's greatest stressors. Most bereaved individuals experience a period of acute grief that diminishes in intensity as they adapt to the changes brought about by their loss. Over the past four decades, a growing body of research has focused on a form of prolonged grief that is painful and impairing. There is a substantial and growing evidence base that supports the validity and significance of a grief-related disorder, including the clinical value of being able to diagnose it and provide effective targeted treatment. ICD-11 will include a new diagnosis of prolonged grief disorder (PGD). DSM-5 called this condition persistent complex bereavement disorder (PCBD) and included it in Section III, signaling agreement that a diagnosis is warranted while further research is needed to determine the optimal criteria. Given the remaining uncertainties, reading this literature can be confusing. There is inconsistency in naming the condition (including complicated grief as well as PGD and PCBD) and lack of uniformity in identifying it, with respect to the optimal threshold and timeframe for distinguishing it from normal grief. As an introductory commentary for this Depression and Anxiety special edition on this form of grief, the authors discuss the history, commonalities, and key areas of variability in identifying this condition. We review the state of diagnostic criteria for DSM-5 and the current ICD-11 diagnostic guideline, highlighting the clinical relevance of making this diagnosis.
PMID: 31916663
ISSN: 1520-6394
CID: 4257532
Understanding the impact of complicated grief on combat related posttraumatic stress disorder, guilt, suicide, and functional impairment in a clinical trial of post-9/11 service members and veterans
Simon, Naomi M; Hoeppner, Susanne S; Lubin, Rebecca E; Robinaugh, Donald J; Malgaroli, Matteo; Norman, Sonya B; Acierno, Ron; Goetter, Elizabeth M; Hellberg, Samantha N; Charney, Meredith E; Bui, Eric; Baker, Amanda W; Smith, Erin; Kim, H Myra; Rauch, Sheila A M
BACKGROUND:Complicated grief (CG) is a bereavement-specific syndrome distinct from but commonly comorbid with posttraumatic stress disorder (PTSD). While bereavement is common among military personnel (Simon et al., 2018), there is little research on the impact of CG comorbidity on PTSD treatment outcomes. METHODS:To evaluate the impact of comorbid CG on PTSD treatment outcomes we analyzed data from a randomized trial comparing prolonged exposure, sertraline, and their combination in veterans with a primary diagnosis of combat-related PTSD (n = 194). Assessment of PTSD, trauma-related guilt, functional impairment, and suicidal ideation and behavior occurred at baseline and weeks 6, 12, and 24 during the 24-week trial. RESULTS:CG was associated with lower PTSD treatment response (odds ratio (OR) = 0.29, 95% confidence interval (CI) [0.12, 0.69], p = 0.005) and remission (OR = 0.28, 95% CI [0.11, 0.71], p = 0.007). Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint. In addition, those with CG were more likely to experience suicidal ideation during the study (CG: 35%, 14/40 vs. no CG 15%, 20/130; OR = 3.01, 95% CI [1.29, 7.02], p = 0.011). CONCLUSIONS:Comorbid CG is associated with elevated PTSD severity and independently associated with poorer endpoint treatment outcomes in veterans with combat-related PTSD, suggesting that screening and additional intervention for CG may be needed.
PMID: 31916660
ISSN: 1520-6394
CID: 4257512
Changes in typical beliefs in response to complicated grief treatment
Skritskaya, Natalia A; Mauro, Christine; Garcia de la Garza, Angel; Meichsner, Franziska; Lebowitz, Barry; Reynolds, Charles F; Simon, Naomi M; Zisook, Sidney; Shear, M Katherine
BACKGROUND:Prolonged grief disorder (PGD) is a new diagnosis in the 11th edition of the International Classification of Diseases, estimated to affect 1 in 10 bereaved people and causing significant distress and impairment. Maladaptive thoughts play an important role in PGD. We have previously validated the typical beliefs questionnaire (TBQ), which contains five kinds of thinking commonly seen in PGD: protesting the death, negative thoughts about the world, needing the person, less grief is wrong, and grieving too much. The current paper examines the role of maladaptive cognition as measured by the TBQ in PGD and its change with treatment. METHODS:Among participants in a multisite clinical trial including 394 adults, we examined (a) the relationship between maladaptive thoughts at baseline and treatment outcomes, (b) the relationship between maladaptive thoughts and suicidality at baseline and posttreatment, and (c) the effect of treatment with and without complicated grief therapy (CGT) on maladaptive thinking. RESULTS:TBQ scores were associated with treatment outcomes and were strongly related to suicidal thinking before and after treatment. TBQ scores showed significantly greater reduction in participants who received CGT with citalopram versus citalopram alone (adjusted mean standard error [SE] difference, -2.45 [0.85]; p = .004) and those who received CGT with placebo versus placebo alone (adjusted mean [SE] difference, -3.44 [0.90]; p < .001). CONCLUSIONS:Maladaptive thoughts, as measured by the TBQ, have clinical and research significance for PGD and its treatment.
PMID: 31804005
ISSN: 1520-6394
CID: 4249972
Complicated grief therapy for clinicians: An evidence-based protocol for mental health practice
Iglewicz, Alana; Shear, M Katherine; Reynolds, Charles F; Simon, Naomi; Lebowitz, Barry; Zisook, Sidney
In the United States alone, about 10 million persons are newly bereaved each year. Most do not require professional intervention or treatment, but many can benefit from targeted support. However, a significant minority of bereaved persons experience intense, prolonged and disabling grief symptoms associated with considerable morbidity and mortality (aka, "Complicated Grief"). Individuals with Complicated Grief require more formal interventions. In this article, we describe a compassionate and evidence-based approach to bereavement-care that can be provided in varied mental health settings. For individuals struggling with acute grief, clinicians can help by providing recognition and acceptance of the grief, eliciting and compassionately listening to their narratives of their relationship with the deceased and the death, and regularly "checking in" regarding their grief experiences. For bereaved persons who are experiencing Complicated Grief, we recommend an evidence-based approach to bereavement-care, complicated grief therapy (CGT), that involves helping the individual accept and cope with the loss while simultaneously assisting them with adaptation to life without the deceased. We describe ways of implementing CGT's seven core themes: (1) understanding and accepting grief, (2) managing painful emotions, (3) planning for a meaningful future, (4) strengthening ongoing relationships, (5) telling the story of the death, (6) learning to live with reminders, and (7) establishing an enduring connection with memories of the person who died. This work can be done in a variety of settings, taking into consideration the needs of the patient, the limitations of the setting, and the skills and experiences of each clinician.
PMID: 31622522
ISSN: 1520-6394
CID: 4140632
Barriers to mental health treatment among individuals with social anxiety disorder and generalized anxiety disorder
Goetter, Elizabeth M; Frumkin, Madelyn R; Palitz, Sophie A; Swee, Michaela B; Baker, Amanda W; Bui, Eric; Simon, Naomi M
Individuals with social anxiety disorder (SAD) or generalized anxiety disorder (GAD) are at risk for not utilizing mental health treatment. The purpose of this research was to examine barriers to treatment in a sample of adults with clinically significant SAD or GAD. Participants were 226 nontreatment-seeking adults with SAD or GAD who underwent semistructured diagnostic interview and received a clinician assessment of symptom severity as part of a clinical research study. Participants completed a self-report measure of barriers to treatment. Individual and combined associations of demographic and symptom severity variables with number of perceived barriers to treatment were examined. Individuals with GAD or SAD endorsed a similar number of overall barriers to treatment. Shame and stigma were the highest cited barriers followed by logistical and financial barriers. Both groups also endorsed not knowing where to seek treatment at high rates. Individuals with greater symptom severity reported more barriers to treatment. Racial and ethnic minorities reported more barriers to treatment even after controlling for symptom severity. Among individuals with GAD or SAD, increased education and culturally sensitive outreach initiatives are needed to reduce barriers to mental health treatment. (PsycINFO Database Record
PMID: 30070552
ISSN: 1939-148x
CID: 3215442
Trauma- and Stressor-Related Disorders
Chapter by: Stoddard, Frederick J., Jr.; Simon, Naomi M.; Pitman, Roger K.
in: American Psychiatric Association Publishing Textbook Of Psychiatry by
pp. 393-436
ISBN:
CID: 4679272
Traumatic distress symptom clusters in complicated grief: Response to treatment [Meeting Abstract]
Na, P; Adhikari, S; Chen, A; Szuhany, K; Suzuki, R; Malgaroli, M; Robinaugh, D; Bui, E; Mauro, C; Zisook, S; Reynolds, C; Shear, M K; Simon, N
Background: Complicated grief (CG) is hypothesized to include both attachment and traumatic distress symptoms, and a preliminary diagnosis has been placed in the trauma and stressor related DSM-5 category (APA, 2013). Posttraumatic stress disorder (PTSD) and CG often present comorbidly, and both result from a major stressor (Simon et al., 2007; Marques et al., 2013; Lenferink et al., 2018). Preliminary data suggest posttraumatic stress symptoms (PTSS) may be present across patients with CG, and not vary by whether the loss is violent or accidental in nature such as required for PTSD diagnoses (Simon et al., 2013; Kersting et al., 2011). Much less is known about how PTSS changes with CG targeted treatment, whether this change is impacted by the nature of the death, or whether it may be necessary to target PTSS separately from grief to improve functional outcomes.
Method(s): Participants were 395 individuals (mean age +/- SD = 53.0 +/- 14.5 years; 78.0% women) with a primary diagnosis of CG based on structured clinical interviews and an Inventory of Complicated Grief (ICG) score>=30. Data were derived from the previously published 20-week multi-center RCT of complicated grief therapy plus pill placebo (CGT + PLA), CGT plus citalopram (CGT + CIT), citalopram (CIT), or placebo (PLA) (Shear et al., 2016). DSM-IV PTSS were assessed using the 17-item self-report Davidson Trauma Scale (DTS). DTS total score of 40 was proposed by the developers of the scale as a cut-off for a diagnosis of PTSD, and has been frequently used as a threshold in previous studies (Davidson et al., 1997; Kastello et al., 2016; Khitab et al., 2013). Our primary analysis examined the adjusted mean difference from baseline in the DTS total and subscale scores (i.e., intrusion, avoidance-numbing, hyperarousal) over three follow-up periods (week 12, 16, and 20) by treatment arm using longitudinal mixed effects regression with participant specific random intercepts. In follow-up analyses, we investigated whether cause of death (violent vs. nonviolent) moderated the relationship between treatments and DTS total score by introducing interaction terms between cause of death and treatment arms in the mixed effects regression model.
Result(s): In the full sample, the mean DTS total score at baseline was 63.2 +/- 27.2, and 77.7% (n = 307) had DTS>=40. There was a general decreasing trend of mean DTS total scores over the 20-week period with a mean adjusted reduction of 27.4 points (d = 0.6) from baseline to week 12 (p < 0.001), and a reduction of 30.7 points (d = 0.7) from baseline to week 20 (p < 0.001). There was no significant difference in change in DTS total score at week 12 by treatment group. However, at weeks 16 and 20, CGT + PLA and CGT + CIT were each associated with a significant DTS reduction compared to placebo alone, while CIT was not. For CGT + PLA vs. PLA, there was 8.8 point (d = 0.14) greater reduction in DTS total score from baseline to week 16 (p = 0.01), and 12.5 point (d = 0.19) greater reduction from baseline to week 20 (p < 0.001). For CGT + CIT vs PLA, there was a 10.0 point (d = 0.15) greater reduction in adjusted DTS total score from baseline to week 16 (p < 0.001), and 10.7 point (d = 0.16) greater decrease from baseline to week 20 (p < 0.001). Similar trends were observed for DTS subscales-CGT + PLA and CGT + CIT demonstrated consistent reduction compared to PLA. In the model with interaction terms between treatments and cause of death, the decrease in DTS score for CGT + CIT compared to PLA was 9.5 points (d = 0.12) greater for those who had violent death compared to those who did not experience violent death (p = 0.04). For CGT + CIT vs CGT + PLA, however, the reduction in DTS total score was 4.2 points (d = 0.04) greater in those who experienced violent death compared to those who did not, but the difference was not statistically significant (p = 0.53).
Conclusion(s): Adults with primary CG assigned to CGT with or without medication demonstrated a significantly larger reduction in PTSS compared to pill placebo, whereas citalopram alone did not. These data parallel findings from the primary study findings for grief (Shear et al., 2016), and demonstrate that CGT may be an effective intervention for PTSS in those with CG. A high level of PTSS were present in this primary CG sample, and PTSS were comparable at baseline for those with violent and non-violent losses. For those who lost someone to violent death, while these data found initial support for greater PTSS reduction for combination therapy with CGT and citalopram compared to placebo, we did not find evidence for a significant benefit of combined therapy over CGT alone for CG due to violent loss. More research is needed to fully understand the role of traumatic distress and its optimal treatment in CG
EMBASE:631798774
ISSN: 1740-634x
CID: 4456552